PREPAREDNESS AGAINST ILLEGITIMATE USE OF BACTERIAL PATHOGENS
Release Date: October 5, 1999
RFA: AI-00-004
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: December 10, 1999
Application Receipt Date: January 19, 2000
THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME"
CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD
APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING
APPLICATIONS IN RESPONSE TO THIS RFA.
PURPOSE
The purpose of this Request for Applications (RFA) is to
support basic research on molecular and genetic aspects of
pathogenesis of, and host immune/defense responses to, the
following bacterial pathogens: Bacillus anthracis,Yersinia
pestis, Francisella tularensis, Coxiella burnetii, or
Brucella species. It is hoped that research from funded
projects will be used to devise appropriate defense
strategies that can be implemented shortly before or soon
after bioterrorist acts.
HEALTHY PEOPLE 2000
The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of
"Healthy People 2000," a PHS-led national activity for
setting priority areas. This RFA, PREPAREDNESS AGAINST
ILLEGITIMATE USE OF BACTERIAL PATHOGENS, is related to the
priority area of immunization and infectious diseases.
Potential applicants may obtain a copy of "Healthy People
2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign for-
profit and non-profit organizations; public and private
institutions, such as universities, colleges, hospitals,
laboratories, units of State and local governments; and
eligible agencies of the Federal government. Racial/ethnic
minority individuals, women, and persons with disabilities
are encouraged to apply as Principal Investigators.
MECHANISM OF SUPPORT
Specific application instructions have been modified to
reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining
efforts being examined by the NIH. Complete and detailed
instructions and information on Modular Grant applications
can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm
The mechanisms of support will be the individual research
project grant (R01) and the Small (Pilot) Research Project
Grant (R03). The total requested project period for an
application submitted in response to this RFA should not
exceed four years for an R01 or three years for an R03.
Responsibility for the planning, direction, and execution of
the proposed project will be solely that of the applicant.
NIAID uses R03 grants to support small, highly innovative or
pilot projects. Applicants for R03 grants may request up to
$50,000 annual direct costs for a period not to exceed three
(3) years. Funds and time requested should be appropriate
for the research proposed.
This RFA is a one-time solicitation. Future competing
renewal applications will compete with all investigator-
initiated applications and will be reviewed according to
customary referral and review procedures.
FUNDS AVAILABLE
The estimated total funds (direct and facilities and
administration [F&A] costs) available for the first year of
support for all awards made under this RFA will be $ 1.0
million; depending on Fiscal Year budget appropriations,
this amount may increase. In Fiscal Year 2000, the NIAID
plans to fund approximately 3-5 awards. The usual PHS
policies governing grants administration and management will
apply. Although this program is provided for in the
financial plans of the NIAID, awards pursuant to this RFA
are contingent upon the availability of funds for this
purpose and the receipt of a sufficient number of
applications of high scientific merit. Funding beyond the
first and subsequent years of the grant will be contingent
upon satisfactory progress during the preceding years and
availability of funds.
RESEARCH OBJECTIVES
Background
In recent years, there has been a significant change in both
the nature and degree of the threat posed by the use of
weapons of biological warfare. The increased risk of misuse
of infectious agents as weapons of terror, as well as
instruments of warfare has prompted the Congress of the
United States to pass statutes to protect the public from
the illegitimate use of bacterial pathogens such as Bacillus
anthracis, Yersinia pestis, Francisella tularensis, Coxiella
burnetii, and Brucella species.
Under normal circumstances, the incidence of naturally
occurring infections caused by these bacterial pathogens is
extremely low in the United States. For this reason, the
cadre of investigators conducting basic research on these
agents is small and of limited scope. Substantial gaps in
our knowledge concerning mechanisms involved in host
immune/defense responses and pathogenesis exists.
Specifically directed research is essential in order to
devise appropriate protective strategies that could be
implemented soon after– or shortly before - a bioterrorist
incident.
Research Objectives and Scope
Research proposals submitted in response to this RFA must
demonstrate that they are relevant to one or more of the
following objectives:
o Identification and characterization of key biochemical,
molecular, or genetic processes (or factors) that contribute
to virulence, pathogenesis, and/or host
resistance/susceptibility with potential for use as
candidate targets for new vaccines, drug intervention, or
immunotherapy to limit in vivo growth or negate the
deleterious effects of those bacterial pathogens described
above.
o Design of novel therapeutic strategies, that can be
implemented soon after a bioterrorist event, to prevent the
germination of bacterial spores in vivo (in the case of
anthrax), arrest or interrupt the spread of infection in
vivo, and/or neutralize -or block-the synthesis of toxins
(or other microbial products) that damage host tissues early
during infection.
o Develop novel or improved candidate vaccines that will
generate significant protective immunity against aerosol
challenge within a relatively short period of time after
immunization with a minimal number of doses, as well as
define serologic correlates or measures of the degree of
protective immunity.
Although appropriate animal models may be used to acquire
and evaluate the experimental data obtained, the development
of a new animal model should not be the major focus of a
proposal submitted in response to this RFA.
Proposals on the development of methods for the rapid
detection of these bacterial pathogens, as well as for the
rapid diagnosis of the infections they elicit, would be of
value in the development of a comprehensive response to
bioterrorism. However, such proposals should be submitted
for consideration and funding as Small Business Innovation
Research (SBIR) or Small Business Technology Transfer (STTR)
grants, not in response to this RFA.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING
HUMAN SUBJECTS
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included
in all NIH supported biomedical and behavioral research
projects involving human subjects, unless a clear,
compelling rationale, and justification are provided that
inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research. This policy
results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing research involving human
subjects should read the "NIH Guidelines for Inclusion of
Women and Minorities as Subjects in Clinical Research",
published in the Federal Register of March 28, 1994 (FR 59
14508-14513) and the NIH Guide for Grants and Contracts,
Vol. 23, No. 11, March 18, 1994 which is available via the
WWW at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html
NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS
PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
It is the policy of NIH that children (i.e., individuals
under the age of 21) must be included in all human subjects
research, conducted or supported by the NIH, unless there
are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications
submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines on the
Inclusion of Children as Participants in Research Involving
Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and which is available
at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may obtain copies from these sources or from
Phillip J. Baker, Ph.D. (listed in INQUIRIES below) who may
also provide additional relevant information concerning the
policy.
LETTER OF INTENT
Prospective applicants are asked to submit, by December 10,
1999, a letter of intent that includes a descriptive title
of the overall proposed research; the name, address and
telephone number of the Principal Investigator; and the
number and title of this RFA. Although the letter of intent
is not required, is not binding, does not commit the sender
to submit an application, and does not enter into the review
of subsequent applications, the information that it contains
allows NIAID staff to estimate the potential review workload
and to avoid conflict of interest in the review. The letter
of intent is to be sent to Madelon Halula, Ph.D. at the
address listed under INQUIRIES.
APPLICATION PROCEDURES
Applicants are strongly encouraged to call NIAID program
staff with any questions regarding the responsiveness of
their proposed project to the goals of this RFA.
The modular grant concept establishes specific modules in
which direct costs may be requested as well as a maximum
level for requested budgets. Only limited budgetary
information is required under this approach. The
just-in-time concept allows applicants to submit certain
information only when there is a possibility for an award.
It is anticipated that these changes will reduce the
administrative burden for the applicants, reviewers and
Institute staff. The research grant application form PHS
398 (rev. 4/98) is to be used in applying for these grants,
with the modifications noted below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in
$25,000 modules. For R03 applications an annual maximum
direct cost of $50,000 may be for up to three years. R01s
requesting up to a total direct cost request of $250,000 per
year must use the modular application format. Applications
that request more than $250,000 direct costs in any year
must follow the traditional PHS398 application instructions.
For modular grant applications, the total direct costs must
be requested in accordance with the program guidelines and
the modifications made to the standard PHS 398 application
instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating
Direct Costs (in $25,000 increments up to a maximum of
$250,000) and Total Costs [Modular Total Direct plus
Facilities and Administrative (F&A) costs] for the initial
budget period Items 8a and 8b should be completed indicating
the Direct and Total Costs for the entire proposed period of
support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not
complete Form Page 4 of the PHS 398. It is not required and
will not be accepted with the application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not
complete the categorical budget table on Form Page 5 of the
PHS 398. It is not required and will not be accepted with
the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant
Budget Narrative page. (See
http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At
the
top of the page, enter the total direct costs requested for
each year. This is not a Form page.
o Under Personnel, List key project personnel, including
their names, percent of effort, and roles on the project. No
individual salary information should be provided. However,
the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student
compensation in developing the budget request.
For Consortium/Contractual costs, provide an estimate of
total costs (direct plus facilities and administrative) for
each year, each rounded to the nearest $1,000. List the
individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort
of key personnel, and the role on the project. Indicate
whether the collaborating institution is foreign or
domestic. The total cost for a consortium/contractual
arrangement is included in the overall requested modular
direct cost amount. Include the Letter of Intent to
establish a consortium.
Provide an additional narrative budget justification for any
variation in the number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides
information used by reviewers in the assessment of each
individual's qualifications for a specific role in the
proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch
is required for all key personnel, following the
instructions below. No more than three pages may be used for
each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form
page;
- List position(s) and any honors;
- Provide information, including overall goals and
responsibilities, on research projects ongoing or completed
during the last three years.
- List selected peer-reviewed publications, with full
citations;
o CHECKLIST - This page should be completed and submitted
with the application. If the facilities and administation
(F&A) rate agreement has been established, indicate the type
of agreement and the date. All appropriate exclusions must
be applied in the calculation of the F&A costs for the
initial budget period and all future budget years.
o The applicant should provide the name and phone number of
the individual to contact concerning fiscal and
administrative issues if additional information is necessary
following the initial review.
Applications are to be submitted on the grant application
for PHS 398 (rev. 4/98). These forms are available at most
institutional offices of sponsored research; from the
Division of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/435-0714,
email: grantsinfo@nih.gov; and on the internet at
http://grants.nih.gov/grants/funding/phs398/phs398.html
For purposes of identification and processing, item 2a on
the face page of the application must be marked "YES" and
the RFA number "AI-99-014" and the words "PREPAREDNESS
AGAINST ILLEGITIMATE USE OF BACTERIAL PATHOGENS" must be
entered on the face page.
The RFA label and line 2 of the application should both
indicate the RFA number. The RFA label must be affixed to
the bottom of the face page. Failure to use this label
could result in delayed processing of the application such
that it may not reach the review committee in time for
review.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has
been modified to allow for this change. Please note this is
in pdf format.
Applications must be received by January 19, 2000.
Applications not received as a single package on the receipt
date or not conforming to the instructions contained in PHS
398 (rev. 4/98) Application Kit (as modified in, and
superseded by, the special instructions below, for the
purposes of this RFA), will be judged non-responsive and
will be returned to the applicant.
If the application submitted in response to this RFA is
substantially similar to a grant application already
submitted to the NIH for review, but that has not yet been
reviewed, the applicant will be asked to withdraw either the
pending application or the new one. Simultaneous submission
of identical applications will not be allowed, nor will
essentially identical applications be reviewed by different
review committees. Therefore, an application that is
essentially identical to one that has already been reviewed
cannot be submitted in response to this RFA. This does not
preclude the submission of substantial revisions of
applications already reviewed, but such applications must
include an introduction addressing the previous critique.
Submit a signed, typewritten original of the application,
including the checklist, and three signed, exact, single-
sided photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express mail or courier service)
At the time of submission, two additional exact copies of
the grant application and all five sets of any appendix
material must be sent to Madelon Halula at the address
listed under INQUIRIES.
Applicants from institutions that have a General Clinical
Research Center (GCRC) funded by the NIH National Center for
Research Resources may wish to identify the GCRC as a
resource for conducting the proposed research. If so, a
letter of agreement from either the GCRC Program Director or
Principal Investigator should be included with the
application.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness
and adherence to the Special Instructions above by the NIH
Center for Scientific Review and for responsiveness by NIAID
staff; those judged to be incomplete or not in the format
specified in this RFA will be returned to the applicant
without review. Those considered to be non-responsive will
be returned without review.
Applications that are complete and responsive to the RFA
will be evaluated for scientific and technical merit by an
appropriate peer review group convened by NIAID in
accordance with the review criteria stated below. As part
of the initial merit review, a process will be used by the
initial review group in which all applications will receive
a written critique but only those applications deemed to
have the highest scientific merit will be discussed,
assigned a priority score, and receive a second level review
by the National Advisory Allergy and Infectious Diseases
Council.
Review Criteria
The five criteria to be used in the evaluation of grant
applications are listed below. To put those criteria in
context, the following information is contained in
instructions to the peer reviewers.
The goals of NIH-supported research are to advance our
understanding of biological systems, improve the control of
disease, and enhance health. The reviewers will comment on
the following aspects of the application in their written
critiques in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of
these goals. Each of these criteria will be addressed and
considered by the reviewers in assigning the overall score
weighting them as appropriate for each application. Note
that the application does not need to be strong in all
categories to be judged likely to have a major scientific
impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that
by its nature is not innovative but is essential to move a
field forward.
1. Significance. Does this study address an important
problem? If the aims of the application are achieved, how
will scientific knowledge be advanced? What will be the
effect of these studies on the concepts or methods that
drive this field?
2. Approach. Are the conceptual framework, design,
methods, and analyses adequately developed, well-integrated,
and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider
alternative tactics?
3. Innovation. Does the project employ novel concepts,
approaches or method? Are the aims original and innovative?
Does the project challenge existing paradigms or develop new
methodologies or technologies?
4. Investigator. Is the investigator appropriately trained
and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the
principal investigator and other researchers (if any)?
5. Environment. Does the scientific environment in which
the work will be done contribute to the probability of
success? Do the proposed experiments take advantage of
unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of
institutional support?
In addition to the above criteria, in accordance with NIH
policy, all applications will also be reviewed with respect
to the following:
o The adequacy of plans to include both genders, minorities
and their subgroups, and children as appropriate for the
scientific goals of the research. Plans for the recruitment
and retention of subjects will also be evaluated.
o The reasonableness of the proposed budget and duration in
relation to the proposed research
o The adequacy of the proposed protection for humans,
animals or the environment, to the extent they may be
adversely affected by the project proposed in the
application.
The personnel category will be reviewed for appropriate
staffing based on the requested percent effort. The direct
costs budget request will be reviewed for consistency with
the proposed methods and specific aims. For modular grant
applications, any budgetary adjustments recommended by the
reviewers will be in $25,000 modules. The duration of
support will be reviewed to determine if it is appropriate
to ensure successful completion of the requested scope of
the project.
AWARD CRITERIA
Funding decisions will be made on the basis of scientific
and technical merit as determined by peer review, program
balance, and the availability of funds. The earliest
anticipated date of award is September 15, 2000.
INQUIRIES
Written and telephone inquiries concerning this RFA are
encouraged. The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic (research scope and
eligibility) issues to:
Phillip J. Baker, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Dr., MSC 7630, Room 3114
Bethesda, MD 20892-7630
Telephone: (301) 435-2855
FAX: (301) 402-2508
E-Mail: pb26o@nih.gov
Direct inquiries regarding review issues and special
instructions for application preparation; address the letter
of intent to; and mail two copies of the application and all
five sets of appendices to:
Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Dr., MSC 7616, Room 2150
Bethesda, MD 20892-7616
Telephone: (301) 402-2636
FAX: (301) 402-2638
E-Mail: mh30x@nih.gov
Direct inquiries regarding fiscal matters to:
Annette Hanopole
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Dr., MSC 7614, Room 2122
Bethesda, MD 20892-7614
Telephone: (301) 496-7075
Fax: (301) 480-3780
E-mail: ahanopole@niaid.nih.gov
Schedule
Letter of intent receipt date: December 10, 1999
Application receipt date: January 19 2000
Scientific review date: May, 2000
Advisory Council date: June,2000
Earliest award date: September, 2000
AUTHORITY AND REGULATIONS
This program is supported under authorization of the Public
Health Service Act, Sec. 301 (c), Public Law 78-410, as
amended. The Catalogue of Federal Domestic Assistance
Citations are Sec. 93.856, Microbiology and Infectious
Diseases Research, and No. 93.855 - Immunology, Allergy, and
Transplantation Research. Awards will be administered under
PHS grants policies and Federal Regulations 42 CFR Part 52
and 45 CFR Part 74. This program is not subject to the
intergovernmental review requirements of Executive Order
12372 or Health Systems review.
The Public Health Service strongly encourages all grant and
contract recipients to provide a smoke-free workplace and
promote the non-use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or, in some cases, any
portion of a facility) in which regular or routine
education, library, day care, health care or early childhood
development services are provided to children. This is
consistent with the PHS mission to protect and advance the
physical and mental health of the American people.